Skip to content

Bone Material Comparison in Maxillary Sinus Augmentation

Bone Quality and Quantity in the Maxillary Sinus Grafted With Xenograft or Synthetic Bone Substitute: A Radiographic and Histomorphometric Randomized Controlled Clinical Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04433117
Enrollment
24
Registered
2020-06-16
Start date
2020-06-17
Completion date
2023-03-01
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Resorption, Sequela, Tooth Extrusion

Keywords

Sinus pneumatization, Socket preservation, Sinus augmentation

Brief summary

Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction when socket preservation is not applied. In addition, extraction of posterior maxillary teeth causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main challenges for dental implant placement. Different bone substitutes have been used to augment bone in pneumatized maxillary sinuses. Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a viable alternative. Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with xenografts revealed newly formed bone to be mostly woven bone with some remodeling to lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to be an effective method for maxillary sinus grafting and demonstrate limited resorption over time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully integrate based on recent histomorphometric studies. Vascularization and trabecular bone formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3 salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis). ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3) allowing for the uptake of calcium ions from the physiological solution and releasing phosphate and silicate ions which aid in bone formation. A material with such properties will substitute bone in a more controlled and effective combination that can be obtained in many clinical situations, without the disadvantages found with autograft. ShefaBone has demonstrated successful regenerative properties for bony defects. To our knowledge, there is no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary sinus. This aim of this current study is to compare SCPC to commonly used xenograft material in an augmented maxillary sinus.

Detailed description

1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of dental implants and subsequent restorations, approximately 20 patients will be randomly assigned to receive an augmentation of the maxillary sinus region using either Shefabone (synthetic bone) or Bio-Oss (xenograft). 2. With the use of pre-operative and post-operative limited view CBCT (cone-beam computed tomography) radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Shefabone and the individuals receiving xenograft material. 3. Histomorphometric analysis will be used to assess, compare and contrast the quality and the quantity of the new vital bone cells generated when using these different graft materials.

Interventions

BIOLOGICALShefabone

Silica-calcium phosphate composite.

BIOLOGICALBio-Oss

Xenograft Bone substitute. Bone from animals.

Sponsors

Mohanad Al-Sabbagh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomized controlled clinical trial. Entails 2 groups of subjects which will be randomly assigned. Group 1 will be the control group, and group 2 is test group.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 20 to 75 years of age * at least one maxillary edentulous posterior site requiring maxillary sinus grafting and replacement with a dental implant.

Exclusion criteria

* current smokers/tobacco users * are pregnant * have active periodontal disease * have uncontrolled diabetes * have any autoimmune disease * have kidney disease * have liver disease * are receiving radiation or chemotherapy * have any type of radiographic periapical pathology such as a periapical abscess.

Design outcomes

Primary

MeasureTime frameDescription
Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements5 monthsBone density will be measured by limited view CBCT radiography pre- and post-operatively.

Secondary

MeasureTime frameDescription
Bone Quality5.5 monthsBone quality will be measured using histomorphometric analysis.

Countries

United States

Participant flow

Pre-assignment details

24 participants were consented for the study but 2 did not meet eligibility criteria and did not receive an intervention

Participants by arm

ArmCount
Control Group
Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material. Bio-Oss: Xenograft Bone substitute. Bone from animals.
15
Test Group
The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute. Shefabone: Silica-calcium phosphate composite.
7
Total22

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicControl GroupTest GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants2 Participants10 Participants
Age, Categorical
Between 18 and 65 years
7 Participants5 Participants12 Participants
Age, Continuous62.7 years
STANDARD_DEVIATION 12.4
63.4 years
STANDARD_DEVIATION 9.9
62.9 years
STANDARD_DEVIATION 11.5
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants7 Participants22 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants6 Participants20 Participants
Region of Enrollment
United States
15 participants7 participants22 participants
Sex: Female, Male
Female
8 Participants2 Participants10 Participants
Sex: Female, Male
Male
7 Participants5 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 7
other
Total, other adverse events
0 / 140 / 7
serious
Total, serious adverse events
0 / 140 / 7

Outcome results

Primary

Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements

Bone density will be measured by limited view CBCT radiography pre- and post-operatively.

Time frame: 5 months

Population: Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment

ArmMeasureValue (MEAN)Dispersion
Control GroupBone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements14.4 percentage of bone height shrinkageStandard Deviation 3.9
Test GroupBone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements1.5 percentage of bone height shrinkageStandard Deviation 8
Secondary

Bone Quality

Bone quality will be measured using histomorphometric analysis.

Time frame: 5.5 months

Population: Data was incomplete for 4 subjects due to poor diagnostic quality or missed appointment

ArmMeasureValue (MEAN)Dispersion
Control GroupBone Quality60 percentage of mineralized bone formationStandard Deviation 0
Test GroupBone Quality100 percentage of mineralized bone formationStandard Deviation 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026